CDISC Blog

Dr. Steven Hirschfeld, from the NIH National Institute of Child Health and Development (NICHD), is the leader of the U.S. National Children’s Study. He is also a director on the CDISC Board of Directors. Although he was a prominent contributor on Monday and Tuesday in Brussels at the CDISC Board meeting, he was required at meetings in the U.S. on Thursday and partnered with Bron to give his presentation at the Interchange. (Dr. Hirschfeld spent Wednesday in meetings at the European Commission in Brussels to partner with the EU on pediatric health initiatives). The key messages from Dr. Hirschfeld’s work include the importance of standards to ensure that data can be shared from ~ 100 sites using different technologies over the lifetime of a ‘child’ from infancy through age 21 and to accept these data into a common aggregated database.

Not only are the standards important for moving the data but also to support sophisticated analyses. The NICHD started with the CDISC standards (which support elements across all studies) and then added the required Operational Standards (needed to track personnel, equipment and other such aspects of a huge research study) and also developed a set of standards specific to pediatric cases. Pediatric studies require addressing different stages of development, e.g. lung function, which change over the course of childhood. The plan is to vet these NICHD standards for pediatrics and operations through the CDISC process for comment solicitation and reconciliation such that they can become open CDISC standards.

The next presentation in this session was on work being done at the Uppsala Monitoring Center. They have a project to move the WHO Drug Dictionary “into the 21st Century with CDISC standards”. Ola Strandberg reported on this project, called the “WHO Drug Dictionary Enhanced”. The desired solution addresses at least 10 items such as: to focus on solving the business problems (e.g. coding a concomitant medication or screening a patient), to facilitate/enforce coding conventions, to present appropriate data for the tasks at hand and to have the result be easily implementable and scalable. They are considering using CDISC ODM for this purpose, since ODM would technically support their requirements.

The final presentation of this Thursday afternoon session was given by Dr. Pierre-Yves Lastic on behalf of Christele Daniel. It was on the EHR4CR project, which is an Innovative Medicines Initiative (IMI) project. This was a very good lead-in to the final plenary session of the CDISC EU Interchange, which will be reported on in the next CDISC blog.